Modified Ablation Catheter Guided Transseptal Puncture under ICE Guidance

Modified Ablation Catheter Guided Transseptal Puncture under ICE Guidance | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Modified Ablation Catheter Guided Transseptal Puncture under ICE Guidance Pan Hou, Rong Wang, Chenchen Hou, Li Liu, Feng Lin, Lewei He, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5350652/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 23 Dec, 2025 Read the published version in BMC Cardiovascular Disorders → Version 1 posted 4 You are reading this latest preprint version Abstract Background Zero-fluoroscopy procedures have become increasingly popular in electrophysiological interventional surgery. As the key technology to achieve zero-fluoroscopy, traditional transseptal puncture (TSP) under ICE guidance has some disadvantages, which limit its promotion and development. We aim to introduce, evaluate the efficiency and safety of a modified TSP technique distilled from practice with the potential to overcome the shortcomings of traditional TSP. Methods A total of 77 patients underwent atrial fibrillation radiofrequency ablation from March 1,2022 to February 28, 2023 were enrolled. 44 patients underwent traditional ICE guided transseptal puncture and 33 patients underwent advanced ICE guided transseptal puncture. Then success rate, attempts of puncture, puncture duration, proportion of ideal puncture location and incidence of puncture related complications were recorded subsequently. Results There were no significant differences in baseline data between the two groups. The number of puncture times (1.25 ± 0.44 vs.1.06 ± 0.24, p = 0.018) and puncture duration (2.52 ± 0.83 vs.3.94 ± 2.15, p = 0.001) of advanced method were significantly less than traditional method. There were no significant differences in the success rate of puncture, the proportion of ideal puncture location and the incidence of puncture related complications between the two groups. Conclusions This study presents a modified ablation catheter guided transseptal puncture under ICE guidance, which simplifies the operation of the puncture component and does not require ICE view tracking. This method has the advantages of high success rate, safety, simple steps, convenient use, and short learning curve, and is worthy of promotion and application. ICE guidance ablation catheter guidance transseptal puncture. Figures Figure 1 1. INTRODUCTION Transseptal puncture (TSP) is the most used procedure in interventional cardiology. It is widely used for ablation of left atrial arrhythmia, percutaneous closure of the left atrial appendage, and interventional treatment of mitral valve disease. This procedure was first described by Ross and Cope in 1958. [ 1 , 2 ] Then in the 1880s, with the extensive development of percutaneous valve replacement and pulmonary vein isolation, it was gradually popularized. [ 3 ] Traditional TSP is usually completed under the guidance of X-ray, but in this condition, the puncture site is determined by anatomic relationship, which requires extremely high requirements on the operator's anatomical knowledge and operation techniques. At the same time, radiation damage has always been a problem, for both patients and operators. In recent years, with the widespread application of new technologies and devices such as intracardiac echocardiography (ICE) and three-dimensional electroanatomic mapping (EAM), the concept of three-dimensional, zero-fluoroscopy TSP has gradually gained popularity. Zero-fluoroscopy TSP techniques guided by ICE and EAM have been reported worldwide and their safety and effectiveness have been extensively validated.[ 4 ] Compared with the traditional X-ray guided TSP technique, ICE guided TSP can display the fossa ovale(FO), adjacent anatomical structures and puncture components in real time, reducing X-ray exposure and improving the success rate of puncture, especially in complex anatomical conditions. The EAM guided TSP can directly present a 3D perspective and accurately locate the FO through the potential mapping, greatly improving the success rate and safety of the puncture.[ 5 ] However, the ICE guided TSP operates under a two-dimensional ultrasound view, which makes it difficult to track the puncturing components in practice, leading to potential safety risks. EAM-guided TSP relies on mapping the FO potential, which requires high technical accuracy and is not suitable for patients with small differences between the central and peripheral potentials of the FO. Considering the above issues, based on previous studies, we explore a modified ablation catheter-guided TSP method with ICE guidance. This approach combines the advantages of 2D ultrasound and 3D modeling with the advantages of simple manipulation, 3D visualization, and high security, which are summarized below. 2. MATERIALS AND METHODS 2.1 Study design and population The study was a single-center, non-randomized controlled observational study. All the selected patients were 18–80 years old who met the criteria for ablation of atrial fibrillation, and the following conditions were excluded: (1) left atrial appendage thrombosis; (2) Anteroposterior diameter of left atrium is greater than 50mm; (3) Structural heart diseases such as atrial septal after occlusion, severe valvular disease, tetralogy of Fallot, etc. (4) other conditions that are not suitable for ablation: fever, severe heart failure, advanced tumors, etc. Patients or the public were not involved in the design, or conduct, or reporting, or dissemination plans of our research. Two different technical approaches (Traditional and Modified) for TSP are described below. 2.2 Modified Ablation Catheter Guidance TSP under ICE guidance. The modified ablation catheter guided transseptal puncture with ICE guidance is our original technical approach. The workflow is described below and shown in Fig. 1 . 2.2.1 Construct a 3D model and select a preset puncture site via a 3D ICE catheter. The ICE catheter(SOUNDSTAR, Biosense Webster, Diamond Bar, CA) was sent to the middle of the right atrium (RA) through the right/left femoral vein. A 3D-model of RA, FO, coronary sinus (CS), left and right pulmonary veins, esophagus (ESO) and left atrium (LA) are constructed respectively along the short axis view of the LA. When the ICE view points to the middle of the left pulmonary vein (LPV) via the FO (the LPV view), the mid-inferior location of the FO is selected as the preset puncture site. Mark this site on the ICE view and 3D model, and ensure that the preset puncture site is lower than the anterior inferior rim of the right inferior pulmonary ostium. There should also be ample space reserved between the puncture site and the anterior rim of the right inferior pulmonary vein for the manipulation of the ablation catheter. 2.2.2 Localization of the ablation catheter on the FO with the interaction of three and two dimensions : Refer to the left atrial 3D model, the ICE catheter is positioned to display the LPV view (" rabbit ear sign"), and appropriate P curve was given to reserve enough operation space for ablation catheter and puncture needle at the atrial septum. the entire atrial septum and FO should be fully shown in the ICE view. Next, the ablation catheter(Thermocool Smart Touch, Biosense Webster, Diamond Bar, CA) was sent to the middle upper part of the right atrium through the SL1 sheath༈St. Jude Medical༉, then was directly delivered to the FO under the guidance of the 3D model. The tip of the ablation catheter is then adjusted and tightly pushed to a preset puncture site marked on the FO. (Tip of the ablation catheter and obvious tenting of the FO are seen via ICE view). At the same time, the ICE view is kept coaxial to the ablation catheter in the 3D model. 2.3 Delivery of the outer sheath along the ablation catheter to the pre punctured site of the FO : The ablation catheter remains stable and the outer sheath is slowly delivered along the ablation catheter to the middle of the FO. In the 3D model, the 1–2 electrodes at the tip of the ablation catheter are progressively covered by the outer sheath. Under the ICE view, keep the tip of the outer sheath tightened over the FO puncture site until a mild tenting of the FO is seen. The ablation catheter is then withdrawn with forward traction of the outer sheath to maintain the tenting of the interatrial septum. During this process, care should be taken to avoid rotation of the ICE view and the outer sheath. After the ablation catheter is withdrawn, the double-track signature of the outer sheath and the tenting sign of the FO puncture site can be seen on the ICE view. 2.4 Delivery of the puncture needle and inner sheath to the middle of the FO : The puncture needle is placed in the inner sheath beforehand. Tighten the FO with the tip of the outer sheath, keeping the tenting sign, and send the needle and inner sheath to the puncture in the middle of the FO. At this point, the visible tenting sign can be seen, and the outer sheath double track sign will disappear from the ICE view. According to the preset ideal puncture site, fine-tune the positions of the puncture site: when the ICE view points to the LAA, it indicates the position is a little further forward; when it points to the rear wall, it indicates that the position is slightly further back; when pointing to the LPV, the position is moderate; when the tentation is near the upper edge of the FO, it indicates a high position; when it is close to the lower edge, it indicates a low position. 2.2.5 Puncture through the atrial septum into the left atrium : (1) Puncture: After the puncture site is confirmed, the complete shape of sheath can be seen on the ICE view, then the needle can be sent forward. When the atrial septum is pierced, the tenting sign disappeared. (2) On the ICE view, the position of the needle tip in the left atrium can be seen; when heparin saline was injected into the needle, eddy current (bubble-like phenomenon) can be seen, this sign can further confirm that the needle tip has entered the LA and show its position. (3) Keep the puncture needle stable and push the inner sheath forward. during the process, a second tenting sign is visible. After the inner sheath enters the LA, the second tenting sign disappears, and the tip of the needle is covered. Next, the outer sheath is advanced as the needle and the inner sheath is pulled out, double-track sign of the outer sheath tube can be seen on ICE view. Finally, the wire was sent to LA. 2.3 Traditional TSP under ICE guidance. The traditional TSP has been described in reference. [ 6 ] The ablation catheter is withdrawn from the SL1 sheath after constructing 3D model. The J-type long guide wire was inserted into the SVC through the SL1 sheath and confirmed by ICE. The SL1 sheath with the dilator is delivered into the SVC via a guide wire guided by ICE. The guide wire is then withdrawn and the puncture needle is placed inside the dilator. Heparin saline was injected into the needle to confirm its location. While the TSP assembly is slowly pulled down in a typical 4 to 7 o’clock position based on the LA anterior–posterior diameter and operator’s experience, the ICE catheter should be adjusted slightly to continuously monitor the position of the TSP assembly tip, When the TSP assembly is pulled down into the FO, the tenting sign can be seen on ICE. The subsequent steps are performed in the same manner as described in the above section. 2.4 Outcomes The following outcomes of TSP were measured: (1).TSP success rate: more than three attempts or TSP time longer than 5 minutes was defined as failure, whether change another operator or require a change to TSP guided by X-ray fluoroscopy and ICE;(2). Ideal puncture site: The distance between the actual puncture site and the preset one is within 3 mm. (3) TSP time༚interval between placement of the ablation catheter to the middle of the RA and flushing the outer sheath with the physiological solution in the LA. (4). Safety evaluation༚incidence rate of major complications related to the TSP. (Cardiac tamponade, pericardial effusion, perforation of the aortic root, stroke/transient ischemic attack etc.). 2.5. Statistical analysis Statistical analysis was performed with SPSS statistical software (IBM, Version 21). Normally distributed continuous variables were expressed as the mean ± standard deviation and non-uniformly distributed data are expressed as medians (Q1 and Q3). The categorical variables are expressed as counts and percentages. Between-group comparisons of means were analyzed by independent-samples t test for normally distributed data and by Mann-Whitney U test for non-uniformly distributed data. The chi-squared test or Fisher test is used for categorical variables. A P-value < 0.05 was considered statistically significant. 3. RESULTS 3.1 Baseline characteristics There were 77 AF patients enrolled in our study. During ablation procedure, 44 patients underwent traditional ICE guided transseptal puncture and 33 patients underwent advanced ICE guided transseptal puncture. There were no statistically significant differences between the groups in baseline characteristics. Details are given in Table 1 . 3.2 Comparison of outcomes between groups. We measure success rate, attempt of punctures, transseptal duration, ideal puncture site rate, and TSP related complications between the two technical approaches. As shown in Table 2 , the success rate of both puncture methods was 100%, and no complications occurred. The puncture times of the modified ICE guided atrial septal puncture method was 1.06 ± 0.24, which was less than that of the traditional method (1.25 ± 0.44, p = 0.018). The average puncture time of the modified ICE guided atrial septal puncture method was 2.52 ± 0.83, which was faster than traditional method (3.94 ± 2.15, p = 0.001). Both the difference were statistically significant. While ideal puncture site rate between two groups has no statistically significant differences, 32(97.0%) vs. 44(90.9%), p = 0.548. Table 1 Baseline patient characteristics Traditional TSP (n = 44) Modified TSP(n = 33) P value Age, y 61.5 ± 11.2 61.8 ± 13.7 0.915 Male, n (%) 24(54.5) 20(60.6) 0.647 BMI, kg/m2 24.2 ± 3.6 24.4 ± 2.7 0.732 LAD, mm 41.3 ± 6.9 39.9 ± 5.4 0.306 LVEF, % 61.5 ± 7.1 63.2 ± 5.0 0.250 NT-pro BNP, ng/ml 605.6 ± 849.5 696.8 ± 1226.8 0.701 Hypertension, n (%) 21(47.7) 14(42.4) 0.817 Diabetes, n (%) 5(11.4) 8(24.4) 0.218 CHD, n (%) 10(22.7) 6(18.2) 0.778 HF, n (%) 11(25.0) 7(21.2) 0.789 Cerebral infarction, n (%) 4(9.1) 4(12.1) 0.718 PAD, n (%) 0(0.0) 3(3.9) 0.075 BMI, body mass index; LAD, left atrial diameter; LVEF, left ventricular ejection fraction; CHD, coronary heart disease; HF, heart failure; PAD, peripheral arterial disease. Table 2 Comparison of outcomes between groups. Traditional TSP (n = 44) Modified TSP(n = 33) P value Success rate, n (%) 44(100) 33(100) - Attempt of punctures, times 1.25 ± 0.44 1.06 ± 0.24 0.018 Transseptal duration, min 3.94 ± 2.15 2.52 ± 0.83 0.001 Ideal puncture site rate, n (%) 40(90.9) 32(97.0) 0.548 TSP related complications, n 0 0 4. DISSCUSION TSP is an essential skill for electrophysiologists. Ideal TSP approach should be easy and safe. Traditional X-ray guided TSP is widely used and has a mature process with high acceptance. However, the X-ray guided TSP infers the puncture site through 2D anatomical structures. On the one hand, this indirect method of inference may deviate from the actual situation, leading to puncture failure or even serious complications. On the other hand, it would be difficult to complete the puncture in the presence of anatomical variation. [ 7 ] In addition, radiation damage should not be ignored, whether to patients, operators, or DSA room staff. With the application of ICE, EAM et al, a growing number of electrophysiologists have realized that radiation-free surgery will be an inevitable development for TSP and even electrophysiological interventional diagnosis and treatment in the future. [ 8 ] ICE enables real-time dynamic visualization of cardiac structure and adjacency relations. Under ICE guidance, radiation-free TSP has become safer. The use of ICE-guided TSP has been "Recommended" during AF radiofrequency ablation, which is evaluated as effectively improving the success rate of TSP and reducing the incidence of complications, especially in cases of overly large or too tiny atria and anatomical variation of the atrial septal. [ 9 ] At present, ICE-guided TSP mainly include ICE view tracking, ablation catheter guided steerable sheath to the FO [ 4 ], ICE combined with T3D [ 10 ] et.al. Based on previous experience, our study creatively proposes a modified ablation catheter-guided TSP under ICE guidance. It has the following advantages over the currently applied transseptal puncture method: 1. ICE modeling to simplify operation and optimize modeling details. Baykaner et al [ 4 ] have introduced an ablation catheter-guided TSP which is similar to our method. The difference lies mainly in the modeling method. According to Baykaner’s description, the ablation catheter was guided by a long wire to the right chamber for modeling, in our modified method, after the modeling is completed by ICE, the ablation catheter can be directly sent to FO under the two-dimensional and three-dimensional interaction. Compared with ablation catheter modeling, ICE catheter modeling is more realistic and more accurate in displaying anatomical details, which is conducive to positioning and puncture.[ 11 ] This improvement gives full play to the advantages of ICE and simplifies the steps such as wire guidance. 2. Operation of puncturing modules is simplified. Most current approaches to TSP guided by ICE must directly manipulate the puncture module to locate the puncture points. “ICE view tracking” requires guiding the puncture modules along the guide wire to the SVC and then pulling it down to the FO. However, guide wires are difficult to place when there are anatomical variations in the right atrium. “Ablation catheter guided puncture modules” delivers puncture modules to the root of SVC through ablation catheter. Although the difficult problem of wire placement can be solved, the puncture module still needs to be gradually withdrawn to locate the FO puncture site, and the angle of the withdrawal is relatively demanding. The ablation catheter guiding a steerable sheath to the FO can direct the puncture module sheath to the FO, but the use of a steerable sheath and a special TSP needle increases the cost.[ 12 ] Studies have shown that TSP failure is mainly caused by inability to locate the FO. [ 13 ] The method described in this paper locate the FO through ablation catheter under ICE guidance, the "needle modules operation" was transformed into the "ablation catheter operation". As is well understood, ablation catheters are more controllable, which significantly improves success rates and safety. Subsequently, along the ablation catheter and the outer sheath, the puncture needle is placed directly on the puncture site, and the puncture is completed only by fine adjustments. 3. Fixed ICE view. “ICE view tracking” is a method widely used in TSP. In this procedure, the ICE view requires real-time tracking of the puncturing module from the SVC to the FO. This process requires constant adjustment of the ICE catheter and passive "searching" for the puncture modules. It is easy for the sector to shift and cause the sheath to disappear from ICE's view. Not only are the technical requirements for surgeons and assistants higher, but security risks are also increased. It's not easy for beginners, either. However, in our modified TSP, only one ICE view is required for the puncturing process, and the whole process can be completed under direct vision without excessive manipulation and tuning. It effectively avoided failure due to the inability of ICE to synchronize the motion of the needle sheath. 4. Simpler process, higher success rate and easier to learn. As described above, the operation of the ICE, ablation catheter and puncture modules are relatively independent and simple in our modified approach, which considerably improves the success rate of TSP and makes it easier to implement zero-fluoroscopy. Simplification of operational procedures and reduction of operational technical requirements are supposed to reduce the incidence of complications. In practice at our center, the success rate is 100 percent, with no post-operative complications. In one word, the improved manipulation method is more user-friendly and has a shorter learning curve for beginners. After mastering it, only one operator can complete the whole puncturing process, which is simpler, more convenient, and more reliable! 5. LIMITATIONS First, the limited number of cases, especially those with anatomical variations, makes it difficult to adequately evaluate the modified TSP. Second, this is a single-center, non-controlled observational study that can only compare methods at a technical level, but not directly analyze their success rates, complication rates, and learning curves. Additional rigorous experimental designs are required for future comparisons. 6. CONCLUSION The modified TSP technique simplifies the needle module operation and does not require ICE view tracking. It has the advantages of high success rate, security, ease of use, and deserves to be popularized and applied. Declarations Ethics approval and consent to participate This study was approved by Ethics Committee of PLA Central Military Command General Hospital(Approval No.[2023]069 − 01).All the study followed the principle of clinical Trial. Clinical trial number: not applicable. Consent for publication Not applicable. Competing interests The authors declare no potential conflict of interests. Funding Not applicable. Author Contribution Pan Hou: Methodology, Formal analysis, Data Curation, Writing - Original DraftRong Wang Formal analysis, Data CurationChenchen Hou Formal analysis, Data CurationLi Liu：Data acquisitionFeng Lin：Data acquisitionLewei He：Data acquisitionShifang Ding: Conceptualization, Methodology, Writing - Review & EditingQing Lu, Conceptualization, Methodology, Writing - Review & Editing Acknowledgements Not applicable. Availability of data and material All data generated or analyzed during this study are included in this published article. References Ross J Jr, Braunwald E, Morrow AG. Transseptal left atrial puncture; new technique for the measurement of left atrial pressure in man. Am J Cardiol. 1959;3(5):653–5. COPE C. Technique for transseptal catheterization of the left atrium; preliminary report. J Thorac Surg. 1959;37(4):482–6. Alkhouli M, Rihal CS, Holmes DR Jr.. Transseptal Techniques for Emerging Structural Heart Interventions. JACC Cardiovasc Interv. 2016;9(24):2465–80. Baykaner T, Quadros KK, Thosani A, et al. Safety and efficacy of zero fluoroscopy transseptal puncture with different approaches. Pacing Clin Electrophysiol. 2020;43(1):12–8. Yu R, Liu N, Lu J, et al. 3-Dimensional Transseptal Puncture Based on Electrographic Characteristics of Fossa Ovalis: A Fluoroscopy-Free and Echocardiography-Free Method. JACC Cardiovasc Interv. 2020;13(10):1223–32. Li D, Ze F, Yuan CZ, et al. The safety and efficiency of fluoroless site-specific transseptal puncture guided by three-dimensional intracardiac echocardiography. J Interv Card Electrophysiol. 2022;65(3):643–9. Almendarez M, Alvarez-Velasco R, Pascual I, et al. Transseptal puncture: Review of anatomy, techniques, complications and challenges, a critical view. Int J Cardiol. 2022;351:32–8. Holda JP. Radiationless transseptal puncture. Anatol J Cardiol. 2017;17(6):473–4. Jingquan Z, Deyong L, Huimin C, et al. Intracardiac echocardiography Chinese expert consensus. Front Cardiovasc Med. 2022;9:1012731. Zhang G, Cheng L, Liang Z, et al. Zero-fluoroscopy transseptal puncture guided by right atrial electroanatomical mapping combined with intracardiac echocardiography: A single-center experience. Clin Cardiol. 2020;43(9):1009–16. Cappato R, Calkins H, Chen SA, et al. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010;3(1):32–8. McCauley MD, Patel N, Greenberg SJ, et al. Fluoroscopy-free Atrial Transseptal Puncture. Eur J Arrhythm Electrophysiol. 2016;2(2):57–61. De Ponti R, Cappato R, Curnis A, et al. Trans-septal catheterization in the electrophysiology laboratory: data from a multicenter survey spanning 12 years. J Am Coll Cardiol. 2006;47(5):1037–42. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 23 Dec, 2025 Read the published version in BMC Cardiovascular Disorders → Version 1 posted Editorial decision: Revision requested 30 Oct, 2024 Editor assigned by journal 29 Oct, 2024 Submission checks completed at journal 29 Oct, 2024 First submitted to journal 28 Oct, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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INTRODUCTION","content":"\u003cp\u003eTransseptal puncture (TSP) is the most used procedure in interventional cardiology. It is widely used for ablation of left atrial arrhythmia, percutaneous closure of the left atrial appendage, and interventional treatment of mitral valve disease. This procedure was first described by Ross and Cope in 1958. [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] Then in the 1880s, with the extensive development of percutaneous valve replacement and pulmonary vein isolation, it was gradually popularized. [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e] Traditional TSP is usually completed under the guidance of X-ray, but in this condition, the puncture site is determined by anatomic relationship, which requires extremely high requirements on the operator's anatomical knowledge and operation techniques. At the same time, radiation damage has always been a problem, for both patients and operators. In recent years, with the widespread application of new technologies and devices such as intracardiac echocardiography (ICE) and three-dimensional electroanatomic mapping (EAM), the concept of three-dimensional, zero-fluoroscopy TSP has gradually gained popularity. Zero-fluoroscopy TSP techniques guided by ICE and EAM have been reported worldwide and their safety and effectiveness have been extensively validated.[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e] Compared with the traditional X-ray guided TSP technique, ICE guided TSP can display the fossa ovale(FO), adjacent anatomical structures and puncture components in real time, reducing X-ray exposure and improving the success rate of puncture, especially in complex anatomical conditions. The EAM guided TSP can directly present a 3D perspective and accurately locate the FO through the potential mapping, greatly improving the success rate and safety of the puncture.[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] However, the ICE guided TSP operates under a two-dimensional ultrasound view, which makes it difficult to track the puncturing components in practice, leading to potential safety risks. EAM-guided TSP relies on mapping the FO potential, which requires high technical accuracy and is not suitable for patients with small differences between the central and peripheral potentials of the FO. Considering the above issues, based on previous studies, we explore a modified ablation catheter-guided TSP method with ICE guidance. This approach combines the advantages of 2D ultrasound and 3D modeling with the advantages of simple manipulation, 3D visualization, and high security, which are summarized below.\u003c/p\u003e"},{"header":"2. MATERIALS AND METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n \u003ch2\u003e2.1 Study design and population\u003c/h2\u003e\n \u003cp\u003eThe study was a single-center, non-randomized controlled observational study. All the selected patients were 18\u0026ndash;80 years old who met the criteria for ablation of atrial fibrillation, and the following conditions were excluded: (1) left atrial appendage thrombosis; (2) Anteroposterior diameter of left atrium is greater than 50mm; (3) Structural heart diseases such as atrial septal after occlusion, severe valvular disease, tetralogy of Fallot, etc. (4) other conditions that are not suitable for ablation: fever, severe heart failure, advanced tumors, etc. Patients or the public were not involved in the design, or conduct, or reporting, or dissemination plans of our research. Two different technical approaches (Traditional and Modified) for TSP are described below.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\n \u003ch2\u003e2.2 Modified Ablation Catheter Guidance TSP under ICE guidance.\u003c/h2\u003e\n \u003cp\u003eThe modified ablation catheter guided transseptal puncture with ICE guidance is our original technical approach. The workflow is described below and shown in Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\u003cspan\u003e\n \u003cp\u003e\u003cstrong\u003e2.2.1 Construct a 3D model and select a preset puncture site via a 3D ICE catheter.\u003c/strong\u003e The ICE catheter(SOUNDSTAR, Biosense Webster, Diamond Bar, CA) was sent to the middle of the right atrium (RA) through the right/left femoral vein. A 3D-model of RA, FO, coronary sinus (CS), left and right pulmonary veins, esophagus (ESO) and left atrium (LA) are constructed respectively along the short axis view of the LA. When the ICE view points to the middle of the left pulmonary vein (LPV) via the FO (the LPV view), the mid-inferior location of the FO is selected as the preset puncture site. Mark this site on the ICE view and 3D model, and ensure that the preset puncture site is lower than the anterior inferior rim of the right inferior pulmonary ostium. There should also be ample space reserved between the puncture site and the anterior rim of the right inferior pulmonary vein for the manipulation of the ablation catheter.\u003c/p\u003e\n \u003c/span\u003e \u003cspan\u003e\n \u003cp\u003e\u003cstrong\u003e2.2.2 Localization of the ablation catheter on the FO with the interaction of three and two dimensions\u003c/strong\u003e: Refer to the left atrial 3D model, the ICE catheter is positioned to display the LPV view (\u0026quot; rabbit ear sign\u0026quot;), and appropriate P curve was given to reserve enough operation space for ablation catheter and puncture needle at the atrial septum. the entire atrial septum and FO should be fully shown in the ICE view. Next, the ablation catheter(Thermocool Smart Touch, Biosense Webster, Diamond Bar, CA) was sent to the middle upper part of the right atrium through the SL1 sheath༈St. Jude Medical༉, then was directly delivered to the FO under the guidance of the 3D model. The tip of the ablation catheter is then adjusted and tightly pushed to a preset puncture site marked on the FO. (Tip of the ablation catheter and obvious tenting of the FO are seen via ICE view). At the same time, the ICE view is kept coaxial to the ablation catheter in the 3D model.\u003c/p\u003e\n \u003c/span\u003e \u003cspan\u003e\n \u003cp\u003e\u003cstrong\u003e2.3 Delivery of the outer sheath along the ablation catheter to the pre punctured site of the FO\u003c/strong\u003e: The ablation catheter remains stable and the outer sheath is slowly delivered along the ablation catheter to the middle of the FO. In the 3D model, the 1\u0026ndash;2 electrodes at the tip of the ablation catheter are progressively covered by the outer sheath. Under the ICE view, keep the tip of the outer sheath tightened over the FO puncture site until a mild tenting of the FO is seen. The ablation catheter is then withdrawn with forward traction of the outer sheath to maintain the tenting of the interatrial septum. During this process, care should be taken to avoid rotation of the ICE view and the outer sheath. After the ablation catheter is withdrawn, the double-track signature of the outer sheath and the tenting sign of the FO puncture site can be seen on the ICE view.\u003c/p\u003e\n \u003c/span\u003e \u003cspan\u003e\n \u003cp\u003e\u003cstrong\u003e2.4 Delivery of the puncture needle and inner sheath to the middle of the FO\u003c/strong\u003e: The puncture needle is placed in the inner sheath beforehand. Tighten the FO with the tip of the outer sheath, keeping the tenting sign, and send the needle and inner sheath to the puncture in the middle of the FO. At this point, the visible tenting sign can be seen, and the outer sheath double track sign will disappear from the ICE view. According to the preset ideal puncture site, fine-tune the positions of the puncture site: when the ICE view points to the LAA, it indicates the position is a little further forward; when it points to the rear wall, it indicates that the position is slightly further back; when pointing to the LPV, the position is moderate; when the tentation is near the upper edge of the FO, it indicates a high position; when it is close to the lower edge, it indicates a low position.\u003c/p\u003e\n \u003c/span\u003e \u003cspan\u003e\n \u003cp\u003e\u003cstrong\u003e2.2.5 Puncture through the atrial septum into the left atrium\u003c/strong\u003e: (1) Puncture: After the puncture site is confirmed, the complete shape of sheath can be seen on the ICE view, then the needle can be sent forward. When the atrial septum is pierced, the tenting sign disappeared. (2) On the ICE view, the position of the needle tip in the left atrium can be seen; when heparin saline was injected into the needle, eddy current (bubble-like phenomenon) can be seen, this sign can further confirm that the needle tip has entered the LA and show its position. (3) Keep the puncture needle stable and push the inner sheath forward. during the process, a second tenting sign is visible. After the inner sheath enters the LA, the second tenting sign disappears, and the tip of the needle is covered. Next, the outer sheath is advanced as the needle and the inner sheath is pulled out, double-track sign of the outer sheath tube can be seen on ICE view. Finally, the wire was sent to LA.\u003c/p\u003e\n \u003c/span\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\n \u003ch2\u003e2.3 Traditional TSP under ICE guidance.\u003c/h2\u003e\n \u003cp\u003eThe traditional TSP has been described in reference. [\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e] The ablation catheter is withdrawn from the SL1 sheath after constructing 3D model. The J-type long guide wire was inserted into the SVC through the SL1 sheath and confirmed by ICE. The SL1 sheath with the dilator is delivered into the SVC via a guide wire guided by ICE. The guide wire is then withdrawn and the puncture needle is placed inside the dilator. Heparin saline was injected into the needle to confirm its location. While the TSP assembly is slowly pulled down in a typical 4 to 7 o\u0026rsquo;clock position based on the LA anterior\u0026ndash;posterior diameter and operator\u0026rsquo;s experience, the ICE catheter should be adjusted slightly to continuously monitor the position of the TSP assembly tip, When the TSP assembly is pulled down into the FO, the tenting sign can be seen on ICE. The subsequent steps are performed in the same manner as described in the above section.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\n \u003ch2\u003e2.4 Outcomes\u003c/h2\u003e\n \u003cp\u003eThe following outcomes of TSP were measured: (1).TSP success rate: more than three attempts or TSP time longer than 5 minutes was defined as failure, whether change another operator or require a change to TSP guided by X-ray fluoroscopy and ICE;(2). Ideal puncture site: The distance between the actual puncture site and the preset one is within 3 mm. (3) TSP time༚interval between placement of the ablation catheter to the middle of the RA and flushing the outer sheath with the physiological solution in the LA. (4). Safety evaluation༚incidence rate of major complications related to the TSP. (Cardiac tamponade, pericardial effusion, perforation of the aortic root, stroke/transient ischemic attack etc.).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\n \u003ch2\u003e2.5. Statistical analysis\u003c/h2\u003e\n \u003cp\u003eStatistical analysis was performed with SPSS statistical software (IBM, Version 21). Normally distributed continuous variables were expressed as the mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation and non-uniformly distributed data are expressed as medians (Q1 and Q3). The categorical variables are expressed as counts and percentages. Between-group comparisons of means were analyzed by independent-samples t test for normally distributed data and by Mann-Whitney U test for non-uniformly distributed data. The chi-squared test or Fisher test is used for categorical variables. A P-value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"3. RESULTS","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003e3.1 Baseline characteristics\u003c/h2\u003e \u003cp\u003eThere were 77 AF patients enrolled in our study. During ablation procedure, 44 patients underwent traditional ICE guided transseptal puncture and 33 patients underwent advanced ICE guided transseptal puncture. There were no statistically significant differences between the groups in baseline characteristics. Details are given in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003e3.2 Comparison of outcomes between groups.\u003c/h2\u003e \u003cp\u003eWe measure success rate, attempt of punctures, transseptal duration, ideal puncture site rate, and TSP related complications between the two technical approaches. As shown in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, the success rate of both puncture methods was 100%, and no complications occurred. The puncture times of the modified ICE guided atrial septal puncture method was 1.06\u0026thinsp;\u0026plusmn;\u0026thinsp;0.24, which was less than that of the traditional method (1.25\u0026thinsp;\u0026plusmn;\u0026thinsp;0.44, p\u0026thinsp;=\u0026thinsp;0.018). The average puncture time of the modified ICE guided atrial septal puncture method was 2.52\u0026thinsp;\u0026plusmn;\u0026thinsp;0.83, which was faster than traditional method (3.94\u0026thinsp;\u0026plusmn;\u0026thinsp;2.15, p\u0026thinsp;=\u0026thinsp;0.001). Both the difference were statistically significant. While ideal puncture site rate between two groups has no statistically significant differences, 32(97.0%) vs. 44(90.9%), p\u0026thinsp;=\u0026thinsp;0.548.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline patient characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTraditional TSP (n\u0026thinsp;=\u0026thinsp;44)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eModified TSP(n\u0026thinsp;=\u0026thinsp;33)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge, y\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e61.5\u0026thinsp;\u0026plusmn;\u0026thinsp;11.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e61.8\u0026thinsp;\u0026plusmn;\u0026thinsp;13.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.915\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24(54.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20(60.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.647\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBMI, kg/m2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24.2\u0026thinsp;\u0026plusmn;\u0026thinsp;3.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24.4\u0026thinsp;\u0026plusmn;\u0026thinsp;2.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.732\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLAD, mm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e41.3\u0026thinsp;\u0026plusmn;\u0026thinsp;6.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e39.9\u0026thinsp;\u0026plusmn;\u0026thinsp;5.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.306\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLVEF, %\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e61.5\u0026thinsp;\u0026plusmn;\u0026thinsp;7.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e63.2\u0026thinsp;\u0026plusmn;\u0026thinsp;5.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.250\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNT-pro BNP, ng/ml\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e605.6\u0026thinsp;\u0026plusmn;\u0026thinsp;849.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e696.8\u0026thinsp;\u0026plusmn;\u0026thinsp;1226.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.701\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypertension, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e21(47.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14(42.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.817\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiabetes, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5(11.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8(24.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.218\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCHD, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10(22.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6(18.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.778\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHF, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11(25.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7(21.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.789\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCerebral infarction, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4(9.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4(12.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.718\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePAD, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0(0.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3(3.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.075\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eBMI, body mass index; LAD, left atrial diameter; LVEF, left ventricular ejection fraction; CHD, coronary heart disease; HF, heart failure; PAD, peripheral arterial disease.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of outcomes between groups.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTraditional TSP (n\u0026thinsp;=\u0026thinsp;44)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eModified TSP(n\u0026thinsp;=\u0026thinsp;33)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSuccess rate, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e44(100)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e33(100)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAttempt of punctures, times\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.25\u0026thinsp;\u0026plusmn;\u0026thinsp;0.44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.06\u0026thinsp;\u0026plusmn;\u0026thinsp;0.24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.018\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTransseptal duration, min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.94\u0026thinsp;\u0026plusmn;\u0026thinsp;2.15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.52\u0026thinsp;\u0026plusmn;\u0026thinsp;0.83\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIdeal puncture site rate, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40(90.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e32(97.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.548\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTSP related complications, n\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"4. DISSCUSION","content":"\u003cp\u003eTSP is an essential skill for electrophysiologists. Ideal TSP approach should be easy and safe. Traditional X-ray guided TSP is widely used and has a mature process with high acceptance. However, the X-ray guided TSP infers the puncture site through 2D anatomical structures. On the one hand, this indirect method of inference may deviate from the actual situation, leading to puncture failure or even serious complications. On the other hand, it would be difficult to complete the puncture in the presence of anatomical variation. [\u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e] In addition, radiation damage should not be ignored, whether to patients, operators, or DSA room staff. With the application of ICE, EAM et al, a growing number of electrophysiologists have realized that radiation-free surgery will be an inevitable development for TSP and even electrophysiological interventional diagnosis and treatment in the future. [\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e]\u003c/p\u003e\n\u003cp\u003eICE enables real-time dynamic visualization of cardiac structure and adjacency relations. Under ICE guidance, radiation-free TSP has become safer. The use of ICE-guided TSP has been \u0026quot;Recommended\u0026quot; during AF radiofrequency ablation, which is evaluated as effectively improving the success rate of TSP and reducing the incidence of complications, especially in cases of overly large or too tiny atria and anatomical variation of the atrial septal. [\u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e] At present, ICE-guided TSP mainly include ICE view tracking, ablation catheter guided steerable sheath to the FO [\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e], ICE combined with T3D [\u003cspan class=\"CitationRef\"\u003e10\u003c/span\u003e] et.al. Based on previous experience, our study creatively proposes a modified ablation catheter-guided TSP under ICE guidance. It has the following advantages over the currently applied transseptal puncture method:\u003c/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003e1. \u003cstrong\u003eICE modeling to simplify operation and optimize modeling details.\u003c/strong\u003e Baykaner et al [\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e] have introduced an ablation catheter-guided TSP which is similar to our method. The difference lies mainly in the modeling method. According to Baykaner\u0026rsquo;s description, the ablation catheter was guided by a long wire to the right chamber for modeling, in our modified method, after the modeling is completed by ICE, the ablation catheter can be directly sent to FO under the two-dimensional and three-dimensional interaction. Compared with ablation catheter modeling, ICE catheter modeling is more realistic and more accurate in displaying anatomical details, which is conducive to positioning and puncture.[\u003cspan class=\"CitationRef\"\u003e11\u003c/span\u003e] This improvement gives full play to the advantages of ICE and simplifies the steps such as wire guidance.\u003c/p\u003e\u003cspan\u003e\n \u003cp\u003e\u003cstrong\u003e2. Operation of puncturing modules is simplified.\u003c/strong\u003e Most current approaches to TSP guided by ICE must directly manipulate the puncture module to locate the puncture points. \u0026ldquo;ICE view tracking\u0026rdquo; requires guiding the puncture modules along the guide wire to the SVC and then pulling it down to the FO. However, guide wires are difficult to place when there are anatomical variations in the right atrium. \u0026ldquo;Ablation catheter guided puncture modules\u0026rdquo; delivers puncture modules to the root of SVC through ablation catheter. Although the difficult problem of wire placement can be solved, the puncture module still needs to be gradually withdrawn to locate the FO puncture site, and the angle of the withdrawal is relatively demanding. The ablation catheter guiding a steerable sheath to the FO can direct the puncture module sheath to the FO, but the use of a steerable sheath and a special TSP needle increases the cost.[\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e] Studies have shown that TSP failure is mainly caused by inability to locate the FO. [\u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e] The method described in this paper locate the FO through ablation catheter under ICE guidance, the \u0026quot;needle modules operation\u0026quot; was transformed into the \u0026quot;ablation catheter operation\u0026quot;. As is well understood, ablation catheters are more controllable, which significantly improves success rates and safety. Subsequently, along the ablation catheter and the outer sheath, the puncture needle is placed directly on the puncture site, and the puncture is completed only by fine adjustments.\u003c/p\u003e\n\u003c/span\u003e\u003cspan\u003e\n \u003cp\u003e\u003cstrong\u003e3. Fixed ICE view.\u003c/strong\u003e \u0026ldquo;ICE view tracking\u0026rdquo; is a method widely used in TSP. In this procedure, the ICE view requires real-time tracking of the puncturing module from the SVC to the FO. This process requires constant adjustment of the ICE catheter and passive \u0026quot;searching\u0026quot; for the puncture modules. It is easy for the sector to shift and cause the sheath to disappear from ICE\u0026apos;s view. Not only are the technical requirements for surgeons and assistants higher, but security risks are also increased. It\u0026apos;s not easy for beginners, either. However, in our modified TSP, only one ICE view is required for the puncturing process, and the whole process can be completed under direct vision without excessive manipulation and tuning. It effectively avoided failure due to the inability of ICE to synchronize the motion of the needle sheath.\u003c/p\u003e\n\u003c/span\u003e\u003cspan\u003e\n \u003cp\u003e\u003cstrong\u003e4. Simpler process, higher success rate and easier to learn.\u003c/strong\u003e As described above, the operation of the ICE, ablation catheter and puncture modules are relatively independent and simple in our modified approach, which considerably improves the success rate of TSP and makes it easier to implement zero-fluoroscopy. Simplification of operational procedures and reduction of operational technical requirements are supposed to reduce the incidence of complications. In practice at our center, the success rate is 100 percent, with no post-operative complications. In one word, the improved manipulation method is more user-friendly and has a shorter learning curve for beginners. After mastering it, only one operator can complete the whole puncturing process, which is simpler, more convenient, and more reliable!\u003c/p\u003e\n\u003c/span\u003e"},{"header":"5. LIMITATIONS","content":"\u003cp\u003eFirst, the limited number of cases, especially those with anatomical variations, makes it difficult to adequately evaluate the modified TSP. Second, this is a single-center, non-controlled observational study that can only compare methods at a technical level, but not directly analyze their success rates, complication rates, and learning curves. Additional rigorous experimental designs are required for future comparisons.\u003c/p\u003e"},{"header":"6. CONCLUSION","content":"\u003cp\u003eThe modified TSP technique simplifies the needle module operation and does not require ICE view tracking. It has the advantages of high success rate, security, ease of use, and deserves to be popularized and applied.\u003c/p\u003e"},{"header":"Declarations","content":" \u003cp\u003e \u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e \u003cp\u003e This study was approved by Ethics Committee of PLA Central Military Command General Hospital(Approval No.[2023]069\u0026thinsp;\u0026minus;\u0026thinsp;01).All the study followed the principle of clinical Trial. Clinical trial number: not applicable.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eConsent for publication\u003c/strong\u003e \u003cp\u003eNot applicable.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eCompeting interests\u003c/strong\u003e \u003cp\u003eThe authors declare no potential conflict of interests.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eNot applicable.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003ePan Hou: Methodology, Formal analysis, Data Curation, Writing - Original DraftRong Wang Formal analysis, Data CurationChenchen Hou Formal analysis, Data CurationLi Liu：Data acquisitionFeng Lin：Data acquisitionLewei He：Data acquisitionShifang Ding: Conceptualization, Methodology, Writing - Review \u0026amp; EditingQing Lu, Conceptualization, Methodology, Writing - Review \u0026amp; Editing\u003c/p\u003e\u003ch2\u003eAcknowledgements\u003c/h2\u003e \u003cp\u003eNot applicable.\u003c/p\u003e\u003ch2\u003eAvailability of data and material\u003c/h2\u003e \u003cp\u003eAll data generated or analyzed during this study are included in this published article.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eRoss J Jr, Braunwald E, Morrow AG. Transseptal left atrial puncture; new technique for the measurement of left atrial pressure in man. Am J Cardiol. 1959;3(5):653\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCOPE C. Technique for transseptal catheterization of the left atrium; preliminary report. J Thorac Surg. 1959;37(4):482\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAlkhouli M, Rihal CS, Holmes DR Jr.. Transseptal Techniques for Emerging Structural Heart Interventions. JACC Cardiovasc Interv. 2016;9(24):2465\u0026ndash;80.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBaykaner T, Quadros KK, Thosani A, et al. Safety and efficacy of zero fluoroscopy transseptal puncture with different approaches. Pacing Clin Electrophysiol. 2020;43(1):12\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYu R, Liu N, Lu J, et al. 3-Dimensional Transseptal Puncture Based on Electrographic Characteristics of Fossa Ovalis: A Fluoroscopy-Free and Echocardiography-Free Method. JACC Cardiovasc Interv. 2020;13(10):1223\u0026ndash;32.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLi D, Ze F, Yuan CZ, et al. The safety and efficiency of fluoroless site-specific transseptal puncture guided by three-dimensional intracardiac echocardiography. J Interv Card Electrophysiol. 2022;65(3):643\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAlmendarez M, Alvarez-Velasco R, Pascual I, et al. Transseptal puncture: Review of anatomy, techniques, complications and challenges, a critical view. Int J Cardiol. 2022;351:32\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHolda JP. Radiationless transseptal puncture. Anatol J Cardiol. 2017;17(6):473\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJingquan Z, Deyong L, Huimin C, et al. Intracardiac echocardiography Chinese expert consensus. Front Cardiovasc Med. 2022;9:1012731.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhang G, Cheng L, Liang Z, et al. Zero-fluoroscopy transseptal puncture guided by right atrial electroanatomical mapping combined with intracardiac echocardiography: A single-center experience. Clin Cardiol. 2020;43(9):1009\u0026ndash;16.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCappato R, Calkins H, Chen SA, et al. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010;3(1):32\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMcCauley MD, Patel N, Greenberg SJ, et al. Fluoroscopy-free Atrial Transseptal Puncture. Eur J Arrhythm Electrophysiol. 2016;2(2):57\u0026ndash;61.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDe Ponti R, Cappato R, Curnis A, et al. Trans-septal catheterization in the electrophysiology laboratory: data from a multicenter survey spanning 12 years. J Am Coll Cardiol. 2006;47(5):1037\u0026ndash;42.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-cardiovascular-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bcar","sideBox":"Learn more about [BMC Cardiovascular Disorders](http://bmccardiovascdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bcar/default.aspx","title":"BMC Cardiovascular Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"ICE guidance, ablation catheter guidance, transseptal puncture.","lastPublishedDoi":"10.21203/rs.3.rs-5350652/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5350652/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eZero-fluoroscopy procedures have become increasingly popular in electrophysiological interventional surgery. As the key technology to achieve zero-fluoroscopy, traditional transseptal puncture (TSP) under ICE guidance has some disadvantages, which limit its promotion and development. We aim to introduce, evaluate the efficiency and safety of a modified TSP technique distilled from practice with the potential to overcome the shortcomings of traditional TSP.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA total of 77 patients underwent atrial fibrillation radiofrequency ablation from March 1,2022 to February 28, 2023 were enrolled. 44 patients underwent traditional ICE guided transseptal puncture and 33 patients underwent advanced ICE guided transseptal puncture. Then success rate, attempts of puncture, puncture duration, proportion of ideal puncture location and incidence of puncture related complications were recorded subsequently.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThere were no significant differences in baseline data between the two groups. The number of puncture times (1.25\u0026thinsp;\u0026plusmn;\u0026thinsp;0.44 vs.1.06\u0026thinsp;\u0026plusmn;\u0026thinsp;0.24, p\u0026thinsp;=\u0026thinsp;0.018) and puncture duration (2.52\u0026thinsp;\u0026plusmn;\u0026thinsp;0.83 vs.3.94\u0026thinsp;\u0026plusmn;\u0026thinsp;2.15, p\u0026thinsp;=\u0026thinsp;0.001) of advanced method were significantly less than traditional method. There were no significant differences in the success rate of puncture, the proportion of ideal puncture location and the incidence of puncture related complications between the two groups.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eThis study presents a modified ablation catheter guided transseptal puncture under ICE guidance, which simplifies the operation of the puncture component and does not require ICE view tracking. This method has the advantages of high success rate, safety, simple steps, convenient use, and short learning curve, and is worthy of promotion and application.\u003c/p\u003e","manuscriptTitle":"Modified Ablation Catheter Guided Transseptal Puncture under ICE Guidance","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-11-20 11:00:09","doi":"10.21203/rs.3.rs-5350652/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-10-30T06:30:50+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-10-30T03:10:59+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-10-30T03:10:24+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Cardiovascular Disorders","date":"2024-10-29T03:07:30+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-cardiovascular-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bcar","sideBox":"Learn more about [BMC Cardiovascular Disorders](http://bmccardiovascdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bcar/default.aspx","title":"BMC Cardiovascular Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"2f5cfc6c-3883-47c4-ab94-5c065b79320e","owner":[],"postedDate":"November 20th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-12-29T16:08:19+00:00","versionOfRecord":{"articleIdentity":"rs-5350652","link":"https://doi.org/10.1186/s12872-025-05340-0","journal":{"identity":"bmc-cardiovascular-disorders","isVorOnly":false,"title":"BMC Cardiovascular Disorders"},"publishedOn":"2025-12-23 15:58:17","publishedOnDateReadable":"December 23rd, 2025"},"versionCreatedAt":"2024-11-20 11:00:09","video":"","vorDoi":"10.1186/s12872-025-05340-0","vorDoiUrl":"https://doi.org/10.1186/s12872-025-05340-0","workflowStages":[]},"version":"v1","identity":"rs-5350652","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5350652","identity":"rs-5350652","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}